FDA UDI
In Commercial Distribution
🇺🇸 United States
K3Pro Konus Dental Implants
DI: EAGN50009K3PROS9
·
Model: 50009K3Pro.S
·
Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- K3Pro Konus Dental Implants
- Primary DI
- EAGN50009K3PROS9
- Version / Model
- 50009K3Pro.S
- Catalog Number
- 50009K3Pro.S
- Company Name
- Argon Medical Productions & Vertriebs Gesellschaft mbH & Co. KG
- Labeler DUNS
- 312649568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0f73183b-ef29-466c-af9a-41e26ed05ed7
Device Description
5.0 x 9.0mm K3Pro "Sure" Implant with 3mm Well
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55849 | Screw endosteal dental implant, two-piece | A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EAGN50009K3PROS9 | HIBCC |
Customer Contacts
- Phone
- +17158981434
- [email protected]
- Phone
- +49672130960
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141159 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 3 | Millimeter | |
| Length | 9 | Millimeter | |
| Outer Diameter | 5 | Millimeter |